• CAN/CSA-ISO 16571:16

    Current The latest, up-to-date edition.

    SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-07-2016

    Publisher:  Canadian Standards Association

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Design requirements
    6 Indicating systems
    7 Plume extraction system pipeline
    8 System components
    9 Terminal units
    10 Marking and colour coding
    11 Pipeline installation
    12 Testing, commissioning, and certification of
       the PES
    13 Information to be supplied by the manufacturer
    Annex A (informative) - Types of plume evacuation
            systems
    Annex B (informative) - Healthcare facility policies
            and procedures
    Annex C (informative) - Typical plume capture
            devices and transfer tubings
    Annex D (informative) - Risk management checklist
    Annex E (informative) - Operational management
    Annex F (informative) - Rationale
    Annex G (informative) - Example of procedure for
            testing and commissioning
            for a central system
    Annex H (informative) - Guidelines for flow-generating
            devices consisting of fans or blowers
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices.

    General Product Information - (Show below) - (Hide below)

    Committee TC 121
    Document Type Standard
    Publisher Canadian Standards Association
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    Z7396.1-17 Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems

    Standards Referencing This Book - (Show below) - (Hide below)

    CSA Z305.13 : 2013(R2018) PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS
    CSA Z317.2 : 2010 SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES
    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    Z7396.1-17 Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    CSA Z7396.2 : 2002 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    CSA Z386:2014(R2019) SAFE USE OF LASERS IN HEALTH CARE
    ISO 11197:2016 Medical supply units
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ANSI Z136.3 : 2011 SAFE USE OF LASERS IN HEALTH CARE
    NFPA 115 : 2016 LASER FIRE PROTECTION
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    C22.1HB-15 Canadian Electrical Code Handbook - An Explanation of the Rules of the Canadian Electrical Code, Part I
    EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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